Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving WomenBNB-ICSINCT04280757
Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos
An observational study of Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women
- What is being tested?
- Biopsied ICSI embryos (PGS)
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population include women conceiving by: 1. ICSI-PGS 2. ICSI-non-PGS 3. Spontaneously conceiving women
Who may be able to join
- Singleton pregnant women
- Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)
- Between the age of 20 and 40 years.
- Non-smokers.
- BMI must be between 19 and 40
Who cannot join
- Those with anti-phospholipid syndrome confirmed by serological tests
- Those with any hematological and immunological disorders
- Women with uterine abnormalities have not been corrected.
- Women with systemic diseases that cannot be controlled or managed
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
wael Elbanna Clinic
Cairo, 11865
wael Elbanna, specialist, 00201227760402, waelelbanna@drwaelelbanna.com
About this study
Official title: Ambispective Comparative Cohort Study to Assess the Differences in Development and Growth Patterns of Biopsied and Non-Biopsied ICSI Embryos and Natural Pregnancy Embryos[BNB-ICSI Study]
As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos.
This study is an ambispective, comparative, cohort, observational, single-center study.
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms
Read the detailed description
This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.
The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: biopsied ICSI embryos (PGS)
- Arm 2: none biopsied ICSI embryos
- Arm 3: natural pregnancy embryos
- Being tested
- Biopsied ICSI embryos (PGS)
- Keywords
- fetal growth, biochemical parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsied ICSI embryos (PGS)Procedure or surgery
Biopsied ICSI embryos (PGS)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Biopsied ICSI embryos Receives: Procedure: Biopsied ICSI embryos (PGS) | |
| Arm 2 | Non biopsied ICSI embryos | |
| Arm 3 | Natural pregnancy embryos |
What is being measured
The primary outcome is the main question the study is designed to answer.
First primary endpoint
- Early ultrasound measurements "yolk sac (YS), mean sac diameter (MSD), crown rump length (CRL)", different maternal serum prenatal screening markers for growth and aneuploidy between the three arms* of the study
Measured: At pregnancy
Second primary endpoint
- Second trimetric U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
Measured: At 2nd trimester of pregnancy
Third primary endpoint
- Third-trimester U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
Measured: At 3rd trimester of pregnancy
Secondary outcomes (3)
First secondary endpoint
Miscarriage
Measured: At Labor
Second secondary endpoint
Live-birth weight
Measured: At Labor
Third secondary endpoint
Preterm labor
Measured: At Labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jul 2021
- Primary completionNov 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Fetal Medicine Research Center, Spain
- Responsible party
- Principal investigator, Wael Elbanna, Wael Elbanna Clinic
- Investigators
- Wael Elbanna, Specialist, Study director, Wael Elbanna ClinicEduard Gratacos, Specialist, Principal investigator, fetal medicineManal El-Hinnawi, Specialist, Principal investigator, Wael Elbanna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280757
- Sponsor's protocol ID
- Elbanna_2020_02
- Acronym
- BNB-ICSI
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2020
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Comparative Cohort Study to Assess the Differences in Development and Growth Patterns of Biopsied and Non-Biopsied ICSI Embryos and Natural Pregnancy Embryos[BNB-ICSI Study]
- ClinicalTrials.gov ID
- NCT04280757
- Acronym / sponsor ID
- BNB-ICSI / Elbanna_2020_02
- Keywords
- fetal growth, biochemical parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- Fetal Medicine Research Center, Spain
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos.
This study is an ambispective, comparative, cohort, observational, single-center study.
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms
Detailed description
This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.
The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: biopsied ICSI embryos (PGS)
- Arm 2: none biopsied ICSI embryos
- Arm 3: natural pregnancy embryos
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Procedure: Biopsied ICSI embryos (PGS)Biopsied ICSI embryos |
| Arm 2 | – | –Non biopsied ICSI embryos |
| Arm 3 | – | –Natural pregnancy embryos |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population include women conceiving by: 1. ICSI-PGS 2. ICSI-non-PGS 3. Spontaneously conceiving women
Key inclusion criteria (5 listed)
- Singleton pregnant women
- Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)
- Between the age of 20 and 40 years.
- Non-smokers.
- BMI must be between 19 and 40
Key exclusion criteria (4 listed)
- Those with anti-phospholipid syndrome confirmed by serological tests
- Those with any hematological and immunological disorders
- Women with uterine abnormalities have not been corrected.
- Women with systemic diseases that cannot be controlled or managed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsied ICSI embryos (PGS)Biopsied ICSI embryos (PGS) | Procedure or surgery | Arm 1 |
Primary outcome
First primary endpoint
Time frame: At pregnancy
- Early ultrasound measurements "yolk sac (YS), mean sac diameter (MSD), crown rump length (CRL)", different maternal serum prenatal screening markers for growth and aneuploidy between the three arms* of the study
Second primary endpoint
Time frame: At 2nd trimester of pregnancy
- Second trimetric U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
Third primary endpoint
Time frame: At 3rd trimester of pregnancy
- Third-trimester U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
3 secondary outcomes
First secondary endpoint
Time frame: At Labor
Second secondary endpoint
Time frame: At Labor
Third secondary endpoint
Time frame: At Labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Elbanna, Specialist study director
Wael Elbanna Clinic
Eduard Gratacos, Specialist principal investigator
fetal medicine
Manal El-Hinnawi, Specialist principal investigator
Wael Elbanna Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women, run by Wael Elbanna Clinic at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wael Elbanna, Specialist (00201227760402, waelelbanna@drwaelelbanna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First primary endpoint (time frame: At pregnancy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.